FDA-Device2025-04-23Class II
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Baxter Healthcare Corporation
Hazard
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Sold states
Worldwide distribution.
Affected count
34187 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2025Don't want to check this manually?
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